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additive orthopaedics locking lattice plate
Additive Orthopaedics
Summary: The Additive Orthopaedics Locking Lattice Plate is a medical device used for fracture fixation, particularly in osteoporotic patients. It is primarily used by orthopedic surgeons to stabilize complex fractures.
FDA Clearance Information
Pathway
510K
Number
K170214 ↗
Decision Date
April 13, 2017
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Additive Orthopaedics Locking Lattice Plate was cleared by the FDA via the 510(k) pathway on April 13, 2017. It is manufactured by Additive Orthopaedics and is classified as a Class II device under product code HRS.
What It Is
The Additive Orthopaedics Locking Lattice Plate is a fracture fixation device designed using additive manufacturing techniques. It features a lattice structure that provides enhanced stability and promotes bone ingrowth. This innovative design is particularly beneficial for patients with osteoporotic bone, where traditional fixation methods may fail.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly for the fixation of complex fractures such as those of the proximal humerus. It is ideal for use in patients with compromised bone quality, such as the elderly or those with osteoporosis. The device is typically used in hospital settings by orthopedic surgeons.
Indications for Use
The FDA-cleared indications for this device include its use in stabilizing fractures, especially in osteoporotic patients. It is designed to address the challenges of fracture fixation in bones that are prone to complications like varus collapse.
Practical Considerations
The Additive Orthopaedics Locking Lattice Plate is available in various sizes to accommodate different patient anatomies. It is compatible with standard surgical techniques for fracture fixation. Surgeons should be familiar with the unique handling characteristics of lattice-structured implants.
Related Literature
The linked study examined the biomechanical performance of additively manufactured proximal humerus fracture fixation plates. It compared conventional locking plates with novel designs featuring integrated struts for medial support. The study found that lattice structures may offer enhanced stability and promote bone ingrowth. However, the study was limited by its use of synthetic bones and may not fully replicate clinical conditions.
Frequently Asked Questions
What is the Additive Orthopaedics Locking Lattice Plate used for?
It is used for the fixation of complex fractures, particularly in osteoporotic patients.
What specialties typically use this device?
Orthopedic surgeons commonly use this device in fracture fixation procedures.
What are the FDA-cleared indications?
The device is indicated for stabilizing fractures, especially in patients with osteoporotic bone.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.